Medtronic Stops Distribution and Sale of HeartWare HVAD ... | 合法醫療器材資訊網

2021年8月12日—RecalledProduct·HeartWareHVADSystem·ModelNumbers:SeeFullListofAffectedDevices·DistributionDates:August30,2016toJune3,2021 ...

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.

The recall described in this notice is the same one that was announced in the Stop New Implants of the Medtronic HVAD System – Letter to Health Care Providers[1] on June 3, 2021.

Recalled Product HeartWare HVAD System Model Numbers: See Full List of Affected Devices[2] Distribution Dates: August 30, 2016 to June 3, 2021 Devices Recalled in the U.S.: 4,620 Date Initiated by Firm: June 3, 2021 Device Use

The HeartWare Ventricular Assist Device (HVAD) System is used to help the heart continue to pump blood to the rest of the body. The HVAD system is used as a bridge to cardiac transplants in patients ...

Medtronic Recalls HeartWare HVAD Battery Cables | 合法醫療器材資訊網

Medtronic | 合法醫療器材資訊網

2021年5月12日 — Medtronic, Inc. Recalls Instructions for Use and Patient Manual for HeartWare HVAD System to Update Information about Carrying Case, Driveline ... Read More

Medtronic Recalls HVAD Pump Implant Kits Due to Delayed or ... | 合法醫療器材資訊網

2021年3月1日 — Medtronic is recalling the HVAD Pump Implant Kit because the device may fail to initially start, restart, or have a delay in restarting ... Read More

Medtronic Stops Distribution and Sale of HeartWare HVAD ... | 合法醫療器材資訊網

2021年8月12日 — Recalled Product · HeartWare HVAD System · Model Numbers: See Full List of Affected Devices · Distribution Dates: August 30, 2016 to June 3, 2021 ... Read More

Medtronic Recalls HeartWare HVAD Pump Outflow Graft and ... | 合法醫療器材資訊網

2020年5月28日 — Medtronic Recalls HeartWare HVAD Pump Outflow Graft and Outflow Graft Strain Relief Due to Risk of Breaks and Tears During Set Up. Read More

Medtronic's HeartWare HVAD pump recalls and decision to exit | 合法醫療器材資訊網

2021年6月17日 — Medtronic abruptly pulled its HeartWare Heart Ventricular Assist Device pump system from the market June 3 after a series of Class I recalls ... Read More

Medtronic hit with another Class I recall regarding HeartWare ... | 合法醫療器材資訊網

2021年5月12日 — Medtronic's HeartWare HVAD system, which helps the heart continue to pump blood to the rest of the body, has been plagued with issues all year. Read More

Medtronic pulls HeartWare HVAD pump from market amid ... | 合法醫療器材資訊網

2021年6月3日 — Medtronic abruptly pulled its HeartWare HVAD pump system from the market Thursday after a slew of Class I recalls and numerous reports of ... Read More

Medtronic Heartware Ventricular Assist Device System | 合法醫療器材資訊網

2021年6月25日 — The Medtronic HVADTM System was recalled because it could cause serious harm, including harm to the patient's brain and nervous system, and ... Read More

Medtronic Pulls the Plug on the HVAD System | 合法醫療器材資訊網

2021年6月3日 — In early March, MD+DI reported that Medtronic had recalled the pump implant kit for the HVAD because the device may fail to initially start, ... Read More

相關資訊整理

Medtronic Recalls HeartWare HVAD Battery Cables | 合法醫療器材資訊網

Medtronic | 合法醫療器材資訊網

Medtronic Recalls HVAD Pump Implant Kits Due to Delayed or ... | 合法醫療器材資訊網

Medtronic Stops Distribution and Sale of HeartWare HVAD ... | 合法醫療器材資訊網

Medtronic Recalls HeartWare HVAD Pump Outflow Graft and ... | 合法醫療器材資訊網

Medtronic&#39;s HeartWare HVAD pump recalls and decision to exit | 合法醫療器材資訊網

Medtronic hit with another Class I recall regarding HeartWare ... | 合法醫療器材資訊網

Medtronic pulls HeartWare HVAD pump from market amid ... | 合法醫療器材資訊網

Medtronic Heartware Ventricular Assist Device System | 合法醫療器材資訊網

Medtronic Pulls the Plug on the HVAD System | 合法醫療器材資訊網

Medtronic's HeartWare HVAD pump recalls and decision to exit | 合法醫療器材資訊網